Job Description
As a Senior Quality Control Associate, you will play a pivotal role in ensuring the integrity and accuracy of laboratory systems within our cGMP Quality Control laboratory facilities.
You will be responsible for planning, executing, and documenting the qualification, calibration, and routine maintenance of laboratory equipment and systems.
This is an exciting opportunity to work on cutting-edge technologies in the biotech industry and contribute to the development of innovative solutions.
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Key Responsibilities:
1. Planning and coordinating schedules for Calibration Technicians to ensure seamless execution of maintenance and calibration activities.
2. Managing and tracking all maintenance and calibration activities through the Computerised Maintenance Management System (CMMS).
3. Authoring, owning, and approving Validation Life Cycle documents for computer-related systems, including responsibility for Data Integrity testing and business administration of Laboratory Computer-Related systems.
4. Commissioning new laboratory equipment and facilities, developing lab equipment specifications, writing equipment validation protocols, and associated summary reports.
5. Conducting periodic reviews of instrument validation as part of the validation life cycle, acting as a subject matter expert on instrument validation regulations and procedures.
6. Serving as the point of contact with laboratory equipment vendors and engineers, coordinating equipment repairs and maintenance with vendors/contractors, and conducting equipment maintenance as required.
7. Writing/contributing to equipment operating procedures and manuals, designing and conducting training for QC staff and other department staff as applicable.
8. Project managing Change controls and adhering to Change Control metrics, providing periodic management updates on activities to senior management.
Required Skills and Qualifications
* A minimum of 3 years of laboratory experience in a cGMP laboratory environment, including exposure to analytical instrument validation.
* Knowledge of the methodology and instrumentation used for biopharmaceutical testing.
* Understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record integrity.
* Demonstrated success in managing an equipment qualification or maintenance program is advantageous.
What We Offer
A dynamic and supportive work environment that fosters growth and development.
The opportunity to work on leading-edge technologies in the biotech industry.
A competitive compensation package and excellent benefits.
Ongoing training and professional development opportunities.